Clinical Research Specialist
About The Position
At BiVACOR, we’re developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world. We’re a team united by purpose, working on something truly unprecedented. Every data query you resolve, every site relationship you build, and every protocol you uphold plays a direct role in giving patients another shot at life. If that’s the kind of work that gets you out of bed in the morning, we think you belong here. BiVACOR is looking for a highly motivated Clinical Research Specialist who is well-versed in clinical trial management. In this role, you will oversee trial sites, manage the documentation and data collected during studies, and serve as a key liaison between BiVACOR and investigational site teams. Your collaboration with clinical sites is critical to ensuring trials are conducted ethically while adhering to protocol, applicable regulations, and guidelines — helping us move closer to putting the world’s first Total Artificial Heart into the hands of patients who need it most.
Requirements
- Bachelor’s degree in a life science-related field; advanced degree may substitute for years of experience
- 2–4 years of experience in a clinical trials research environment or equivalent
- General knowledge of regulatory requirements (e.g. TGA, FDA) and Good Clinical Practices (GCP)
- Proficient knowledge of medical terminology and clinical trial documentation requirements, including eTMF management
- Strong interpersonal, collaborative, and time management skills; excellent organizational and communication abilities
- Can-do attitude, detail-oriented and the ability to manage shifting priorities and work across a global team
- Willingness to travel nationally and internationally up to 75% as required to support clinical site activities
Nice To Haves
- CCRA, ACRP, CCRP, SOCRA certification or equivalent preferred
Responsibilities
- Serve as key contact for Clinical Site Research Coordinators and liaise to ensure timely, accurate entry of data into the eCRF, including resolution of data queries
- Provide training to study staff on study protocols and GCP guidelines
- Develop and maintain study timelines and budgets
- Develop study documents and procedures, and conduct study site file (eTMF) maintenance reviews
- Review and maintain clinical trial documents (e.g. informed consents) and analyze clinical trial data for accuracy and completeness
- Perform investigational product (IP) inventory, reconciliation, and review of storage and security
- Ensure sites are conducting activities per protocol, HREC requirements, and executed contracts
- Provide frequent communication to study leadership on site status updates
- Work closely with the extended study team, including CROs, vendors, and trial staff
- Follow standard operating procedures and Good Clinical Practice (GCP) guidelines
Benefits
- 401(k) with company matching
- Medical, dental, and vision insurance
- Health Savings Account (HSA) & Flexible Spending Account (FSA)
- Life insurance & Employee Assistance Program
- Generous paid time off
- A discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
